Bortezomib

Generic Name: Bortezomib

Brand Names: Velcade, Bortezomib Accord, Bortezomib Hospira, Bortezomib Fresenius Kabi, Bortezomib Sun

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₅BN_₄O_₄

CAS Number: 179324-69-7

Unique Ingredient Identifier: 69G8BD63PP

Background: Bortezomib is a dipeptide boronic acid derivative and proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma. The 26S proteasome is a protein complex that degrades ubiquitinated proteins in the ubiquitin-proteasome pathway: reversible inhibition of the 26S proteasome, leading to cell cycle arrest and apoptosis of cancer cells, is thought to be the main mechanism of action of bortezomib. However, multiple mechanisms may be involved in the anticancer activity of bortezomib.

Bortezomib was first synthesized in 1995. In May 2003, bortezomib became the first anticancer proteasome inhibitor that was approved by the FDA under the trade name VELCADE. Phase I, II, III, and IV clinical trials are undergoing to investigate the therapeutic efficacy of bortezomib in leukemia, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, and solid tumours.

Indication: Bortezomib is indicated for the treatment of adults with multiple myeloma or mantle cell lymphoma.

Associated Conditions: Mantle Cell Lymphoma (MCL), Multiple Myeloma (MM)

Associated Therapies: -

Clinical Trials

Bortezomib and Azacitidine in Treating Patients With Relapsed or Refractory T-Cell Lymphoma

Phase 1

Completed

Conditions: Prolymphocytic Leukemia
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Small Intestine Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Angioimmunoblastic T-cell Lymphoma
Hepatosplenic T-cell Lymphoma
Peripheral T-cell Lymphoma

Interventions: Drug: azacitidine
Drug: bortezomib
Procedure: Correlative studies

First Posted Date: 2010-05-24

Last Posted Date: 2013-12-03

Lead Sponsor: Pierluigi Porcu

Target Recruit Count: 8

Registration Number: NCT01129180

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

Bortezomib, Mitoxantrone, Etoposide, and Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Pure Erythroid Leukemia (M6b)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Recurrent Adult Acute Myeloid Leukemia

Interventions: Drug: bortezomib
Drug: mitoxantrone hydrochloride
Drug: etoposide
Drug: cytarabine
Other: flow cytometry

First Posted Date: 2010-05-20

Last Posted Date: 2015-08-13

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 3

Registration Number: NCT01127009

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

Phase 1

Terminated

Conditions: Waldenstrom's Macroglobulinemia

Interventions: Drug: Everolimus
Drug: Rituximab
Drug: Bortezomib

First Posted Date: 2010-05-18

Last Posted Date: 2021-04-23

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 46

Registration Number: NCT01125293

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma

Phase 1

Terminated

Conditions: Mantle Cell Lymphoma

Interventions: Drug: PD 0332991
Drug: bortezomib

First Posted Date: 2010-04-27

Last Posted Date: 2019-06-27

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 20

Registration Number: NCT01111188

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib

First Posted Date: 2010-03-23

Last Posted Date: 2020-09-09

Lead Sponsor: Boston VA Research Institute, Inc.

Target Recruit Count: 50

Registration Number: NCT01090921

Locations: 🇺🇸
West Los Angeles VA Medical Center, Los Angeles, California, United States
🇺🇸
Pittsburgh VA Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸
Atlanta VA Medical Center, Atlanta, Georgia, United States

and more 8 locations

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Phase 1

Completed

Conditions: Chronic Lymphocytic Leukemia
Indolent Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Idelalisib
Drug: Bortezomib
Drug: Rituximab
Drug: Ofatumumab
Drug: Fludarabine
Drug: Everolimus
Drug: Chlorambucil
Drug: Bendamustine
Drug: Lenalidomide

First Posted Date: 2010-03-17

Last Posted Date: 2021-03-18

Lead Sponsor: Gilead Sciences

Target Recruit Count: 241

Registration Number: NCT01088048

Locations: 🇺🇸
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
🇺🇸
Willamette Valley Cancer Institute and Research Center, Springfield, Oregon, United States
🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States

and more 8 locations

Efficacy of Panobinostat in Patients With Relapsed and Bortezomib-refractory Multiple Myeloma

Phase 2

Completed

Conditions: Relapsed and Bortezomib Refractory Multiple Myeloma
Refractory Multiple Myeloma
Multiple Myeloma in Relapse

Interventions: Drug: panobinostat
Drug: bortezomib
Drug: dexamethasone

First Posted Date: 2010-03-10

Last Posted Date: 2017-12-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 55

Registration Number: NCT01083602

Locations: 🇺🇸
Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst., Atlanta, Georgia, United States
🇺🇸
Duke University Medical Center Dept. of DUMC (4), Durham, North Carolina, United States
🇺🇸
MD Anderson Cancer Center/University of Texas MD Anderson CC, Houston, Texas, United States

and more 10 locations

Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis

Phase 2

Completed

Conditions: Amyloidosis

Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Melphalan

First Posted Date: 2010-03-09

Last Posted Date: 2020-09-25

Lead Sponsor: Boston Medical Center

Target Recruit Count: 35

Registration Number: NCT01083316

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States

An Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma

Phase 1

Completed

Conditions: Melanoma

Interventions: Drug: bortezomib
Drug: sorafenib

First Posted Date: 2010-03-02

Last Posted Date: 2016-06-08

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 11

Registration Number: NCT01078961

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant

Phase 2

Terminated

Conditions: Refractory Multiple Myeloma

Interventions: Drug: liposomal doxorubicin
Drug: bortezomib
Drug: dexamethasone
Drug: cyclophosphamide

First Posted Date: 2010-03-02

Last Posted Date: 2015-01-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2

Registration Number: NCT01078441

Locations: 🇺🇸
Graham Hospital Association, Canton, Illinois, United States
🇺🇸
Mason District Hospital, Havana, Illinois, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States

and more 127 locations

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